At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Pilot Clinical Trial of Transfusion of Pathogen Reduced Cryoprecipitated Fibrinogen (INTERCEPT Fibrinogen Complex) in Patients With Bleeding to Expedite Product Availability and Improve Outcomes in Perioperative Bleeding
In Brief
A Phase 4 clinical trial evaluating Traditional Cryoprecipitate and Pathogen-Reduced Cryoprecipitate for Hypofibrinogenemia and Bleeding. Completed, enrolled 208 participants across 1 site.
Detailed Summary
The goal of this quality improvement study is to compare pathogen-reduced cryoprecipitate with traditional cryoprecipitate in liver transplant and cardiovascular patients. The investigators hypothesize that by having immediate access to a readily available thawed blood product that replaces fibrinogen (the main substrate of a blood clot), early bleeding can be treated before it escalates into uncontrolled hemorrhage, and therefore additional blood products, like platelets, plasma and red blood cells can be avoided. Participants will be given one of the two FDA-approved blood products.
Study Details
Timeline
Interventions
This is the cryoprecipitate already currently being given to patients with a cryo order.
This is the pathogen-reduced cryoprecipitate that is intended to be compared to the standard cryoprecipitate.